Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha)....more